Quality Systems Specialist (ISO 9001 / ISO 13485) Engauge is hiring a Quality Systems Specialist to support and continuously improve our Quality Management System (QMS) within a manufacturing environment (plastics experience preferred, not required). We’re looking for someone with strong ISO 9001 experience (ISO 13485 is a plus) who can take ownership of audits, CAPA processes, documentation control, and ERP-based quality systems. What You’ll Do: Maintain and improve QMS in compliance with ISO 9001 & ISO 13485 Manage CAPA processes and corrective actions Utilize ERP system (IQMS) for quality data collection Serve as liaison between customers and the Quality Department What We’re Looking For: 4+ years in a quality systems role Strong ISO 9001 knowledge (required) ISO 13485 exposure (preferred) Experience with audits, CAPA, and document control ERP experience (IQMS preferred) If you're a detail-oriented quality professional ready to make an impact, we’d love to connect. #J-18808-Ljbffr